Is TumorNext-BRCA the right test right for you?
If you’re a woman with ovarian epithelial cancer, this is one of two tests we offer to help you and your clinician identify whether one of the latest treatments available could help you.
It’s called PARP inhibitor treatment and, used in conjunction with chemotherapy, can destroy cancer cells.
The TumorNext-BRCA test is an analysis of two specific genes which can indicate whether your tumour tissue is likely to respond to this treatment – and it can also show if you have a hereditary of risk for other cancers.
Ask your clinician how you can get this test – and also ask about our broader 11-gene TumorNext-HRD test.
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Would PARP inhibitor treatment help you?
Most women who have Ovarian cancer have particular gene mutations in their DNA – specifically those in BRCA1 and BRCA2 genes.
But that is not always the case, and if you have a different gene mutation, a new therapy that could help you is PARP inhibitor treatment.
It involves drugs which block an enzyme used by cancer cells to repair damage caused by chemotherapy to their DNA, but it doesn’t affect healthy cells. In effect, it causes tumour cells to die.
This test analyses your BRCA1 and BRCA2 genes – if no mutations are found, this gives you and your clinician a clear indication that targeted PARP inhibitor treatment will help you.
Hereditary risk of other cancers
However, if you do have BRCA1 and BRCA2 gene mutations, this is an indication that you may have a hereditary risk of developing other cancers – and this knowledge will enable you to plan further screening or monitoring in the future.
Your TumorNext-BRCA test analysis can also indicate if other members of your family have significantly increased risk of cancer – so they too can arrange for appropriate monitoring or screening.
You can discuss this with your clinician, or if you would like to talk to one of our experts about this test, call us on +44 (0) 1270 623 179.
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What do I need to do?
This test is an analysis of your tumour tissue. You will have had a biopsy before you received your cancer diagnosis, and we can use the sample taken at that time so you do not need an additional medical procedure to take this test.
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Through your clinician
This test is only available through your clinician, who will receive your test results directly.
Step 1: Purchase and permission
Buy the test. You will receive an email asking you to confirm that you have authorised Everything Genetic Ltd to be given a sample of your tumour tissue.
Step 2: Collection of sample
We will contact your pathologist directly and organise the collection of your sample and delivery to the laboratory.
Step 3: Analysis and reporting
Your sample will be analysed and a report will be generated, usually within seven working days of receipt of your sample in the laboratory.
Step 4: Results
Your clinician will receive the analysis showing if there are any mutations in the BRCA1 and BRCA2 genes in your DNA.
This will indicate whether or not PARP inhibitor treatment could help you or if mutations have been identified which are associated with the hereditary risk of developing other cancers, so that you and members of your family can take action to protect your health in future.
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TumorNext BRCA Info for clinicians
The Ambry approach
Ambry places significant value on implementing new lab processes designed to increase quality, and advancing technology across its field with innovative approaches.
Its ongoing participation in numerous research studies and collaborations is designed to help its scientists better assess clinical validity of gene-disease relationships. This is to ensure that the results healthcare providers receive are as accurate and informative as possible: the more accurate the reports, the more insight it can provide you, the Clinician, to treat your patients.
In 2016, Ambry led the largest study of its kind (20,000 cases) to give guidance on additional confirmatory testing: it found specific well-defined thresholds, reducing the chance of delivering a false positive patient report or one that misses real mutations (Mu et al., November 2016).
Ambry Genetics is both CAP-accredited and CLIA-approved.
Its methodology is to detect large deletions and duplications, primarily from next generation sequencing, using additional methods such as MLPA and arrayCGH for confirmation, and as needed for increased detection. Its methods of detecting deletions and duplications have been validated through extensive research of over 30,000 samples analysed using arrayCGH and NGS.
Ambry scientists say: ‘In our research, we identified over 13,000 deletions, duplications, and other structural variants using both methodologies.
‘Our data shows that high quality NGS data can be used to detect these alterations as accurately, if not better, than standalone arrayCGH. We are always optimizing our technology and our detection because at the end of the day, it’s the actionable results we give healthcare providers to better care for their patients that matters most.’
Ovarian epithelial cancer
Women with epithelial ovarian cancer need a reliable test to determine if they are eligible for PARP inhibitor treatment. It may also be helpful to know if they are at risk for other cancers.
TumorNext-HRD (11-gene) and TumorNext-BRCA (2-gene) look at both tumor and germline so that you can get the complete picture and provide timely targeted treatment to patients at a time when they need it most.
Why is this Important?
Tests that look at only tumour tissue do not allow you to identify patients with hereditary cancer and those that look at only germline will miss patients who may benefit from PARP inhibitors. TumorNext-HRD and TumorNext-BRCA do both by detecting and differentiating between germline and somatic mutations in homologous recombination repair genes including BRCA1 and BRCA2 in one simple test so that you can:
- Identify ovarian cancer patients who are at an increased risk for other cancers
- Identify patients who have family members that may be at a significantly increased risk for cancer and clarify management recommendations
- Determine which patients may benefit from targeted treatment with PARP inhibitors
- Increase diagnostic yield by including methylation status and additional HRD genes
When to consider testing
Use TumorNext-BRCA or TumorNext-HRD for your ovarian cancer patients to determine who may be eligible for PARP inhibitor treatment or future eligibility.
- NCCN® recommends BRCA1/2 germline testing for all patients with epithelial ovarian cancer.
- SGO recommends that all women diagnosed with epithelial ovarian, fallopian tube, and peritoneal cancers should consider genetic testing, even in the absence of a family history of cancer.
- Test Description
Paired tumour/germline analysis of BRCA1/BRCA2 plus 9 additional genes* in the homologous recombination repair pathway that are also known to be associated with hereditary cancer, and also includes BRCA1 and RAD51C methylation analysis.
* Additional genes on TumorNext-HRD: ATM, BARD1, BRIP1, CHEK2, MRE11A, NBN, PALB2, RAD51C, RAD51D
This test is provided by:
Frequently asked questions
- Do I need a doctor to authorise this test?
- Yes, your doctor will need to provide the sample required for this test
- Will my health insurance cover the cost of this test?
- Many health insurance plans cover the cost of genetic testing – check with your provider to find out if it is in your policy.
- How soon do I get my results?
- Usually within three to four weeks of receipt of your sample in the laboratory.
- How accurate is the test
- Ambry follows advanced laboratory procedures and ensures quality control to deliver accurate results you can trust.